Agility Symmetric Total Knee System— 510(k) K242412

Substantially Equivalent

Medisurge, LLC

FDA 510(k) clearance K242412 for Agility Symmetric Total Knee System, Substantially Equivalent on 2024-11-06. Applicant: Medisurge, LLC.

Clearance details

Applicant: Medisurge, LLC
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2024-08-14
Decision date: 2024-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.